SynchroMed Infusion System, Ascenda Intrathecal SynchroMed II Clinician Programmer Application
FDA premarket approval P860004/S328 · decided 2019-04-15
Approval details
- PMA number
- P860004
- Supplement
- S328
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- SynchroMed Infusion System, Ascenda Intrathecal SynchroMed II Clinician Programmer Application
- Generic name
- Pump, infusion, implanted, programmable
- Applicant
- Medtronic, Inc.
- Date received
- 2019-03-21
- Decision date
- 2019-04-15
- Days to decision
- 25 days
- Decision code
- APPR
- Product code
- LKK
- Advisory committee
- General Hospital
- Expedited review
- No
- Location
- Minneapolis, MN
- Statement
- Approval for changes to the Medtronic Communicator Model 8880T2 Technical Manual and Clinician Programmer Application labeling.
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510(k) clearances by this applicant
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|---|---|---|
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| Bio-Medicus Life Support Catheter and Introducer (K251831) | Medtronic, Inc. | 2026-01-15 |
| Concerto Versa™ Detachable Coil (K253511) | Medtronic, Inc. | 2026-01-14 |
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